BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 6, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Boehringer Ingelheim
- Interventions being studied
- Drug: Pemetrexed; Drug: BIBW 2992; Drug: Cisplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
- Measurable disease according to RECIST 1.1.
- Eastern Cooperative Oncology Group score of 0 or 1.
- Age \>/= 18 years.
- Life expectancy of at least three months.
- Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines.
- Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
- Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
- Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
- Active brain metastases
- Any other current malignancy or malignancy diagnosed within the past five years
- Known pre-existing interstitial lung disease.
- Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
- History or presence of clinically relevant cardiovascular abnormalities.
- Any other concomitant serious illness or organ system dysfunction.
- Adequate absolute neutrophil count and platelet count
- Adequate liver and kidney function
- Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology GroupFayetteville, Arkansas
- Clinical Trials and Research Associates IncMontebello, California
- Innovative Medical Research of South FloridaMiami, Florida
- Crescent City Research ConsortiomMarrero, Louisiana
- Interlakes Foundation, IncorporatedRochester, New York
- Lehigh Valley Hospital / Lehigh Valley Health NetworkAllentown, Pennsylvania
- South Texas Institute of Cancer, Northwest Cancer CenterCorpus Christi, Texas
- Instituto de Medicina Nuclear de Bahía BlancaBahía Blanca
- Hospital AlemánCapital Federal
- Imcaba S.R.L.Capital Federal
- IMAI ResearchCapital Federal
- Instituto Alexander FlemingCapital Federal
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 6, 2018. Always confirm current availability with the study team.